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Dose Escalation Safety and Pharmacokinetic Study of AVE9633 as Single Agent in Relapsed/Refractory CD33-Positive Acute Myeloid Leukemia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00543972
Recruitment Status : Terminated (due to absence of evidence of clinical activity up to toxic doses)
First Posted : October 15, 2007
Last Update Posted : May 14, 2009
Information provided by:

Brief Summary:
The primary objective is to determine the maximum tolerated dose of AVE9633 and to characterize the dose limiting toxicity(ies). Secondary objectives are to determine the anti-leukemia activity, the global safety and the PK profile.

Condition or disease Intervention/treatment Phase
Myeloid Leukemia Drug: AVE9633 Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open Label, Dose-Escalation Safety and Pharmacokinetic Study of AVE9633 Administered as a Single Agent by Intravenous Infusion on Day 1, Day 4 and Day 7 of a 4-Week Cycle in Patients With Relapsed or Refractory CD33-Positive Acute Myeloid Leukemia (AML)
Study Start Date : September 2007
Actual Primary Completion Date : August 2008
Actual Study Completion Date : August 2008

Intervention Details:
  • Drug: AVE9633
    Intravenous Infusion

Primary Outcome Measures :
  1. Incidence of Dose Limiting Toxicity(ies) at each tested dose level [ Time Frame: Study period ]

Secondary Outcome Measures :
  1. Complete Remission (CR) / Remission with incomplete platelet recovery (CRp), Partial Remission (PR) rate, time to CR and duration of CR, peripheral blast clearance [ Time Frame: Study period ]
  2. Incidence of Adverse Events [ Time Frame: Study period ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Patients with CD33-positive acute myeloid leukemia, refractory or relapsed after standard treatment with no curative option available
  • ECOG performance status 0 to 2

Exclusion Criteria:

  • Therapy with gemtuzumab ozogamicin (Mylotarg) within 6 months prior to inclusion
  • Allogenic transplantation within 6 months prior to inclusion
  • Prior therapy (chemotherapy, targeted agents, radiotherapy) within 3 weeks except for hydroxyurea and for leukophoresis
  • Previous treatment with AVE9633
  • Poor kidney, liver and bone marrow functions
  • Any serious active disease or co-morbid condition, which in the opinion of the principle investigator, will interfere with the safety or with compliance with the study
  • Pregnant or breast-feeding women
  • Patient with reproductive potential without effective birth control methods

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00543972

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United States, New Jersey
Sanofi-Aventis Administrative Office
Bridgewater, New Jersey, United States, 08807
Sanofi-Aventis Administrative Office
Paris, France
Sanofi-Aventis Administrative Office
Barcelona, Spain
Sponsors and Collaborators
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Study Director: ICD CSD Sanofi
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Responsible Party: ICD Study Director, sanofi-aventis Identifier: NCT00543972    
Other Study ID Numbers: TED10219
EudraCT 2006-005976-41
First Posted: October 15, 2007    Key Record Dates
Last Update Posted: May 14, 2009
Last Verified: May 2009
Additional relevant MeSH terms:
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Leukemia, Myeloid
Leukemia, Myeloid, Acute
Neoplasms by Histologic Type